Abstract
BackgroundIn patients with metastatic cancer, the bone is the third-most common site of involvement. Radiation to painful bone metastases results in high rates of pain control and is an integral part of bone metastases management. Up to one-third of inpatient consults are requested for painful bone metastases, and up to 60% of these patients had evidence of these lesions visible on prior imaging. Meanwhile recent advances have reduced potential side effects of radiation. Therefore, there is an opportunity to further improve outcomes for patients using prophylactic palliative radiation to manage asymptomatic bone metastases.Methods/study designIn this trial, 74 patients with metastatic solid tumors and high-risk asymptomatic or minimally symptomatic bone metastases will be enrolled and randomized to early palliative radiation or standard of care. This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint. This endpoint was selected to encompass patient-centered outcomes that impact quality of life including pathologic fracture, spinal cord compression, and intervention with surgery or radiation. Secondary endpoints include hospitalizations, Bone Pain Index, pain-free survival, pain-related quality of life, and side effects of radiation therapy.DiscussionIn this study, we propose a novel definition of high-risk bone metastases most likely to benefit from preventive radiation and use validated questionnaires to assess pain and impact on quality of life and health resource utilization. Observations from early patient enrollment have demonstrated robustness of the primary endpoint and need for minor modifications to Bone Pain Index and data collection for opioid use and hospitalizations. With increasing indications for radiation in the oligometastatic setting, this trial aims to improve patient-centered outcomes in the polymetastatic setting.Trial registrationISRCTN Number/Clinical trials.gov, ID:NCT03523351. Registered on 14 May 2018.
Highlights
In patients with metastatic cancer, the bone is the third-most common site of involvement
In this study, we propose a novel definition of high-risk bone metastases most likely to benefit from preventive radiation and use validated questionnaires to assess pain and impact on quality of life and health resource utilization
Defining “high-risk” bone metastases In a retrospective study completed at our institution [13], we found that the most commonly treated sites of bone metastases in inpatients with clinically significant pain were in the spine (51%), joints such as hip and shoulder (11%) and long bones such as femur and humerus (11%)
Summary
Clinical trials of radiation therapy in the setting of bone metastases have historically emphasized palliation, defined as improvement in pain, function, and quality of life after treatment of symptomatic lesions. SREs are supported by retrospective data in the setting of radiation for asymptomatic bone metastases [17] and commonly used in the prophylactic setting for prospective trials of medical therapy [29] Patient selection is another important factor in developing a trial that can facilitate future implementation into routine practice, if findings are positive. To better understand the potential clinical significance of prophylactic palliative radiation for asymptomatic bone metastases, validated patient-centered and health services-related secondary endpoints include pain (measured with a modified BPI), quality of life (measured with EuroQOL EQ-5D-5L), and hospitalizations (a surrogate for health resource utilization). Trial status At the time of writing (January 2020), 40 patients have been accrued (out of 74 planned)
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